Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
Summary: This position provides overall support of the Biovia Discoverant System. It is responsible for overall system maintenance and on-going support of Discoverant and related systems. This position also oversees and coordinates those activities required for the continued development of new system functions and implementation in additional areas and for additional products. This includes management of PAS software development and integration projects from conceptualization through implementation (i.e. define, build, test, deploy); work with area managers to determine business needs for process and laboratory data management.
Essential Duties and Responsibilities include, but are not limited to, the following:
* Works with IT and the user community to identify and develop enhancements and new functionality, design and implementation of improvements to the system and its hierarchies and underlying data model.
* Coordinates installation of new functionality or product release upgrades to various system components, including Discoverant server and client software, PRIMR, and ODBC for Analysis Groups.
* Creates and maintains SOPs concerning Discoverant
-Hierarchy Development and Management:
* Identifies, documents, and communicates new business requirements.
* Designs and creates a comprehensive data model that meets the documented business requirements. A data model consists of PRIMR forms, SQL views to access data from several sources, and a Discoverant hierarchy.
* Identifies specific data points that are needed and determine the related business rules in source databases.
* Designs and develops PRIMR forms through an HTML editor.
-End User Support / Front-Line Technical Support:
* Serves as the primary end user support and troubleshooting resource for the sites/company.
* Manages and resolves all related software and data issues. This includes analysis, debugging, resolution and, when necessary, escalation or vendor coordination.
* Coordinates installation of Discoverant client software for new users.
* Initiates and documents system change control, including service requests and application upgrades (Requirement Specifications, Detail Design Specification, Test Plans and Summary Reports.)
* Establishes and manages security access controls for the application, including filing User Access requests, adding users and groups
* Adds and maintains users, including passwords, enabled/disabled accounts, group memberships, and roles
* Works with external partners for custom hierarchy development
Knowledge and Skills:
Operating Systems and Software:
* Advanced knowledge of SQL and PL/SQL.
* Advanced knowledge of web page designing.
* Historian OPC-HDA data access, preferred but not desired (Kepware, Proficy, Matrikon).
* Basic database administration (DBA) skills for the appropriate databases.
* Knowledge of Life Sciences manufacturing processes, principles, and batch documentation requirements.
* Knowledge of GxP requirements related to computer systems validation, documentation and change control (in the Life Sciences industry).
* Knowledge of laboratory and computer systems;
* Knowledge of cGMP, 21CFR11 and other applicable regulations.
* Data modeling skills for developing and extending hierarchies in Discoverant through the use of provided tools.
* Ability to create data views using standard SQL.
* Database design experience.
* Ability to work with business areas and understand data requirements.
* Project management skills.
* Ability to establish, track, communicate and manage multiple various sized projects, utilizing multi-functional resources.
* Ability to investigate, analyze and resolve problems within a structured methodology.
* Ability to identify training needs and to develop and deliver relevant training materials or programs.
* Ability to effectively communicate issues and ideas with peers and management.
* Demonstrated interpersonal, written, and oral communication skills.
* Ability to build effective working relationships throughout the organization.
Education and Experience:
* Requires BS/BA degree along with 5+ years of related experience in a cGMP environment. A minimum of 3 years of experience with laboratory computerized systems is required.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.